Responsibilities :
- Working on high risk validations in a timely manner particularly in relation to IQ / OQ / PQ and test method validation
- Supporting on equipment CSV and gauge R&R activity
- Liaise with project engineering group to plan, review and witness execution of validations.
- Preparation and update of Validation strategy docs
- Preparation and update of applicable FMEA's
- Review of significant changes relating to transferred equipment versus previous installations,
- Review and approval of Validation protocols for transferred / new equipment and processes
- Work in partnership with Engineering team to ensure quality and achieve improvement initiatives.
Requirements :
- You must hold a bachelor's degree in Life Science, Engineering, Math, Statistics or a similar discipline.
- You will have at least years of experience working in quality functions within the medical device industry, with at least years' experience specifically in validation.
- You will have experience working with a medical device manufacturer in a remediation effort.
- You will have previously worked in test method validation and IQ / OQ / PQ.
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